Devices and methods for approximating the cross-sectional profile of vasculature having branches

ABSTRACT

This disclosure is related to devices and related methods for isolating a treatment region in a human body from fluid pressure. In various embodiments, an implantable device for isolating a treatment region in a human body from fluid pressure comprises a first elongated segment, and a second elongated segment, and one or more branch segments in fluid communication with one of the first elongated segment and the second elongated segment. The elongated segments have a combined cross section that is substantially conformable to an intraluminal cross section of a body lumen into which they are implanted. A method of installing an implantable medical device into the body of a patient comprises deploying a first elongated segment, deploying a second elongated segment, and deploying one or more branch segments in a target region of a vasculature.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/255,407, filed Jan. 23, 2019, which is a continuation of U.S. patentapplication Ser. No. 13/572,328, filed Aug. 10, 2012, now U.S. Pat. No.10,219,922, issued Mar. 5, 2019, which claims the benefit of U.S.Provisional Application 61/523,225, filed Aug. 12, 2011, all of whichare incorporated herein by reference in their entireties for allpurposes.

BACKGROUND Field

This disclosure relates to devices and methods for isolating a treatmentregion from fluid pressure, and more specifically, to providing medicaldevices that adaptably approximate the cross-sectional profile of thevasculature in an area of the vasculature having branch vessels and/oran irregular configuration.

Discussion of the Related Art

Treatment of various portions of the vasculature may require theinstallation of one or more medical devices. In this regard, a medicaldevice can be any device or structure configured to provide and/orsupport a therapeutic use in the vasculature. Commercially availabledevices generally possess specific requirements with regard to thedimensions and configuration of the region to be treated. However, thecross-sectional profile and configuration of the primary vessel beingtreated, the locations at which branch vessels join the primary vesselwith respect to the treatment site, and the configuration and conditionof branch vessels may vary considerably on a patient-by-patient basis ina manner that can significantly affect patient eligibility for treatmentwith available devices. For example, in an abdominal aorta with ananeurysm, the distance between the renal arteries and the aneurysm andthe length of normal-diameter iliac artery available for proximal anddistal attachment can significantly affect patient eligibility foravailable stent devices. Angulation of the attachment site between therenal arteries and the aneurysm can also present significant limitationsto treatment with commercial devices. The status and size of theiliofemoral arteries and their capacity to accommodate insertion ofmedical devices may impose a further limitation on a patient'seligibility for treatment with a particular medical device. Variationsin the anatomical limitations presented by individual patients incombination with the limitations of available devices impose asignificant limitation on patient eligibility for treatment withimplantable medical devices.

For example, FIGS. 1A-1D illustrate a range of possible configurationsof an abdominal aorta. FIG. 1A illustrates a vasculature 101A comprisingan abdominal aorta without an aneurysm as well as major branch arteries,including the renal arteries 110, the superior mesenteric artery (“SMA”)111, the celiac artery 112, the common iliac arteries 113, the externaliliac arteries 114, and the internal iliac arteries 115. FIG. 1Billustrates a vasculature 101B having a “textbook” abdominal aorticaneurysm (“AAA”) 102 with a length of normal aorta proximal (closer tothe heart) to the site of the aneurysm and distal (further from theheart) to the renal arteries, a region referred to as the infrarenalaortic neck 103. An AAA as illustrated in FIG. 1B may be treated withany of a number of commercially available implantable medical devicesthat require a length of normal infrarenal aorta for proximal attachmentof the device within the vasculature.

FIG. 1C illustrates a vasculature 101C having a pararenal AAA, whereinthe aorta lacks a length of normal aorta between the aneurysm and therenal arteries. A patient having a pararenal AAA may be ineligible fortreatment with various commercially available devices that require alength of normal infrarenal aorta for proximal attachment andimplantation. Alternatively, a patient with a pararenal AAA can betreated using chimney or sandwich graft approaches. These approaches mayincrease a risk of leakage around the devices at the treatment site orof device migration.

FIG. 1D illustrates a vasculature 101D having an angulated infrarenalaortic neck 104. As for a pararenal AAA, an abdominal aorta withangulation of the infrarenal aortic neck presents significant challengesfor treatment with implantable medical devices, as most commerciallyavailable medical devices may be unable to conform to thecross-sectional profile of the vasculature. Moreover, the flow throughthe lumens defined by such medical devices may be suboptimal because thecross-sectional profile created by the medical devices at the treatmentsite may not substantially approximate the cross-sectional profile ofthe vasculature.

Thus, a need exists for devices that are adaptable to a variety ofanatomical configurations to expand the scope of patient eligibility fortreatment and to enhance the performance of medical devices implantedinto a body lumen, particularly in patients having irregular or tortuousanatomies.

SUMMARY

In general, the present disclosure provides devices and related methodsfor isolating a treatment region in a human body from fluid pressure.For example, in various embodiments, a branched stent device fortreatment of an abdominal aortic aneurysm is provided that includes twoelongated segments and at least one branch segment in fluidcommunication with an elongated segment. In this example, a combinedcross section of the elongated segments is substantially conformable toan intraluminal cross section of the aorta proximal to the aneurysm,thus isolating the aneurysm from fluid pressure and permitting fluidflow to distal regions through the elongated segments as well as to abranch vessel connected by the branch segment.

A device in accordance with various embodiments can include, forexample, such other features as the ability to position one elongatedsegment independently from another elongated segment, longitudinallydisplaced elongated segments, modular attachment of branch segments tothe elongated segments, and connectors having various structures.

A related method for installing an implantable medical device comprises,in various embodiments, deploying a first elongated segment and a secondelongated segment in a target region of the vasculature and deploying abranch segment in a branch vessel, wherein a combined cross section ofthe first and second elongated segment is substantially conformable toan intraluminal cross section of the vasculature.

A method for installing an implantable medical device in accordance withvarious embodiments can further involve such steps as deployingadditional branch segments, repositioning an elongated segment,positioning an open stent region of an elongated segment, deploying aconnector, and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure,and together with the description, serve to explain the principles ofthe disclosure.

FIGS. 1A-1D illustrate profile views of vasculature comprising abdominalaortas demonstrating a range of conditions and configurations;

FIG. 2 illustrates a device having a first elongated segment, a secondelongated segment, and branch segments in accordance with variousembodiments;

FIGS. 3A-3D illustrate various possible cross-sectional profiles ofelongated segments in accordance with various embodiments;

FIG. 4 illustrates a device with a first elongated segment and a secondelongated segment having open stent regions at the proximal ends of theelongated segments;

FIGS. 5A and 5B illustrate an elongated segment having a branch segmentthat is engaged in both an undeployed conformation and a deployedconformation;

FIGS. 6A and 6B illustrate an elongated segment and a branch segmentthat is modularly engaged to the elongated segment;

FIGS. 7A and 7B illustrate an elongated segment having flange segmentsattached at an end of the elongated segment;

FIGS. 8A-8D illustrate an elongated segment having a flap extendingbeyond the end of the elongated segment and wrapping around and into thelumen of an adjacent elongated segment; and

FIGS. 9A-9C illustrate a profile view and cross-sectional views of adevice comprising two longitudinally displaced elongated segments in avasculature having an angulated infrarenal aortic neck.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The detailed description of various embodiments herein makes referenceto the accompanying drawing figures, which show various embodiments andimplementations thereof by way of illustration and best mode, and not oflimitation. While these embodiments are described in sufficient detailto enable those skilled in the art to practice the embodiments, itshould be understood that other embodiments may be realized and thatmechanical and other changes may be made without departing from thespirit and scope of the present disclosure. Furthermore, any referenceto singular includes plural embodiments, and any reference to more thanone component may include a singular embodiment. Likewise, anyordination of a device or of a component or portion of a device withdesignations such as “first” and “second” is for purposes of convenienceand clarity and should not be construed as limiting or signifying morethan an arbitrary distinction. Moreover, recitation of multipleembodiments having stated features is not intended to exclude otherembodiments having additional features or other embodimentsincorporating different combinations of the stated features.

As used herein, “medical devices” can include, for example stents,grafts, and stent-grafts, (whether single, multicomponent, bifurcated,branched, etc.), catheters, valves, and drug-delivering devices, to namejust a few, that are implanted, acutely or chronically, in thevasculature or other body lumen or cavity at a treatment region.

As used herein, “leakage” means the unwanted or undesirable flow into orthrough a treatment region, where the flow is outside the lumen(s) orbody(ies) defined by the medical device(s), for example into or throughan area such as a “gutter” located between a portion of a device and theadjacent body tissue, between two devices, or at an intersection of aportion of one or more devices and the adjacent body tissue. As usedherein, the term “endoleak” is synonymous with “leakage” and may be usedinterchangeably with “leakage.”

As used herein, an “elliptical” shape refers to any shape that generallylacks a point where two lines, curves, or surfaces converge to form anangle. An “elliptical” shape encompasses traditional Euclidian geometricshapes such as circles and ellipses, as well as other non-angular shapes(that lack any angles), even if those shapes do not have designationscommon in Euclidian geometry.

As used herein, a “non-elliptical” shape refers to any shape thatincludes at least one point where two lines, curves, or surfacesconverge to form an angle. A “non-elliptical” shape encompassestraditional Euclidian geometric shapes such as triangles, squares, andrectangles, as well as other angular shapes (that have at least oneangle) such as crescents, even if those shapes do not have designationscommon in Euclidian geometry.

As used herein, “circumference” means the boundary line formed by anobject, including, for example, an end of a stent or a stent wall at across section anywhere along the length of the stent. A “circumference”can include a boundary line formed by an object having any shape,including elliptical and non-elliptical shapes as defined herein,wherein the shape generally describes a line that encloses an area. A“circumference” can include a boundary line formed by an object or across section thereof regardless of whether the actual surface or crosssection of the object described by the boundary is continuous orinterrupted. For example, an open stent or an object comprising a seriesof separate segments that may or may not physically overlap or makecontact with each other can still describe a “circumference” as usedherein.

As used herein, “substantially conformable” refers to the capacity of anobject to dimensionally conform to another object. The term“substantially conformable” as used herein can describe an object thatis designed and given a predetermined structure and shape that fits intoor against another shape, objects that have predetermined shapes thatare at least in part in complementary to one another while otherportions of the objects may have a shape capable of flexibly andadaptably changing to conform to another object, and objects thatgenerally have the capacity to adapt in shape and/or conformation toother objects without any requirement for designed or predeterminedcomplementarity to another device or object.

As used herein, “independently positionable” refers to a capacity of onecomponent to be inserted, located, moved, and or positioned separatelyfrom another component of a device or system. The term “positionable”includes movement of any type, for example, longitudinal, lateral,rotational, and torsional movements as well as flexing, articulating,and longitudinal and radial expansion and contraction.

As used herein, “reconstrain” refers to a process that involves thereverse of deploying a medical device to an implanted state.“Reconstrain” as used herein has an equivalent meaning to such similarterms as “recapture” and “recover.” “Reconstraining” a device caninvolve partially or fully reversing a deployment of a device by suchmeans as replacing a sheath around the device, compacting the deviceonto a catheter, or otherwise putting the device back in a contracted,compressed, or restricted state. “Reconstraining” may be necessary incertain procedures or using certain devices to reposition, retract, orremove a device. Repositioning can include, for example, longitudinal,lateral, and/or rotational movement of the device within the treatmentsite.

The present disclosure relates to a number of non-limiting embodiments,each of which may be used alone or in coordination with one another. Adevice in accordance with various embodiments can be any suitablemedical device or devices installable within the vasculature or otherbody lumens and configured to provide for isolation of a treatmentregion from fluid pressure. In various embodiments, a device cancomprise one or more elongated segments that substantially approximatethe cross-sectional profile of the vasculature when implanted in atreatment region.

In various embodiments, the devices disclosed herein may comprise acovering material. A covering material may be any biocompatible orbiodegradable material, as described in detail elsewhere herein. Acovering material in accordance with various embodiments forms agenerally continuous surface or surfaces of a component of the device,defining a lumen and an outer surface of the component of the device.The covering material need not be completely continuous, but may beinterrupted by openings at the ends of the elongated segments or branchsegments, open stent regions, and/or fenestrations such as side branchopenings. The covering material may be applied to the device by any of avariety of methods, including, for example, wrapping, forming, ormolding a covering material about a mandrel.

In accordance with various embodiments, a device may comprise suchfeatures as radiopaque markers or similar features that aidvisualization of the device within the body during deployment andpositioning.

In various embodiments, a device may comprise coatings. The coatings ofthe device components may be in contact with other objects includingother devices or device components or interior surfaces of thevasculature, such that the combined cross-section of a first elongatedsegment and a second elongated segment more are substantiallyconformable to the intraluminal cross-sectional of the vasculature.

In various embodiments, the devices disclosed herein may comprise asupport structure (e.g., a stent of any suitable configuration). Thesupport structure may be any suitable material including, for example,stainless steel, nitinol, and the like. The support structure maycomprise a plurality of stent rings. The stent rings may be operativelycoupled to one another with a wire. A wire used to couple stent ringsmay attach to the peak of a first stent ring and a valley of a secondstent ring. The stent ring may be arranged such that the peaks invalleys are in-phase (e.g., the peaks first stent ring share a commoncenterline with the peaks of the second stent) or out of phase (e.g.,the peaks of the first stent ring share a common centerline with thevalleys of the second stent ring).

A device in accordance with various embodiments can comprise a first anda second elongated segment, each having two opposing ends and eachdefining a lumen extending between the ends. The lumens defined by theelongated segments are referred to as primary lumens. Each elongatedsegment may be comprised of two or more separate subsegments that arejoined to form a single elongated segment, as described herein, with thesingle elongated segment comprised of two or more separate subsegmentsdefining a single lumen and having two opposing ends. Furthermore, anyuse of the term “elongated segment” in the present disclosure can alsoinclude “subsegment.” In accordance with various embodiments, the devicecan comprise two or more elongated segments.

In various embodiments and with reference to FIG. 2 , a branched stentdevice comprises two or more elongated segments, such as a firstelongated segment 220 and a second elongated segment 230. Firstelongated segment 220 can be comprised of subsegment 220 a andsubsegment 220 b, and second elongated segment can be comprised ofsubsegment 230 a and subsegment 230 b. First elongated segment 220 canhave a proximally oriented first end 221 and a distally oriented secondend 222, and likewise, second elongated segment 230 can have aproximally oriented first end 231 and a distally oriented second end232. The elongated segments can be deployed at a treatment site in avasculature 201 such as an abdominal aorta having an AAA 202 or otherbody lumen in any suitable configuration. For example, the elongatedsegments can be installed in a configuration to conduct blood or otherbodily fluids between a proximal aortic lumen 205 and distal lumens suchas those of the common iliac arteries 213 and/or one or more side branchvessels such as the renal arteries 210 and the internal iliac arteries215. In the illustrated example, subsegments 220 a and 230 a of firstand second elongated segments 220 and 230 of the device are implanted inthe proximal portion of the treatment region to receive blood fromproximal aortic lumen 205 and perfuse renal arteries 210 via branchfirst branch segment 223 and third branch segment 233, and subsegments220 b and 230 b of the device conduct blood distally to the externaliliac arteries 214 at second ends 222 and 232 of the first and secondelongated segments 220 and 230, as well as to internal iliac arteries215 via second branch segment 224 and fourth branch segment 234. Invarious other embodiments, the distal ends of elongated segments can belocated in other portions of a treatment region, for example, in thecommon iliac arteries 213 or in a region of normal aorta distal to ananeurism. In accordance with various embodiments, first ends 221 and 231and second ends 222 and 232 of first elongated segment 220 and secondelongated segment 230 may be located in any suitable portion of atreatment region.

In various embodiments, one or more elongated segments may be joined toanother medical device. For example, a device comprising two elongatedsegments, similar to subsegments 220 a and 230 a, as illustrated in FIG.2 , can be joined at the distal ends of the elongated segments to aproximal end of a bifurcated stent-graft, wherein the bifurcatedstent-graft functions to deliver blood to the distal portion of thetreatment region. The device comprising two elongated segments can bejoined to the bifurcated stent-graft in a substantially fluid-tightmanner during deployment of the elongated segments. In this manner, adevice in accordance with various embodiments comprising two or moreelongated segments and having branch segments, as described below, canbe deployed in a proximal portion of a treatment region, such as aproximal aorta having renal artery branches, and joined to a secondmedical device, for example, a bifurcated stent-graft suitable forinstallation in a distal portion of a treatment region such as thedistal portion of an aneurysm and the common iliac arteries. Anycombination of a device in accordance with various embodiments deployedin any portion of a treatment region and joined with any other medicaldevice is within the scope of the present disclosure.

In accordance with various embodiments, a first elongated segment and asecond elongated segment have a combined cross section that issubstantially conformable to an intraluminal cross section of a bodylumen. For example, in any portion of vasculature 201 where firstelongated segment 220 and second elongated segment 230 occupy the samecross-sectional profile (e.g., the infrarenal aortic neck 203 or thelocation of first end 221 of the first elongated segment 220 and firstend 231 of the second elongated segment 230 in a proximal aortic lumen205 as illustrated here), first elongated segment 220 and secondelongated segment 230 are substantially conformable to the intraluminalcross section of the vasculature. The substantially conformablecross-sectional profiles of the first elongated segment 220 and thesecond elongated segment 230 have a combined cross section thatsubstantially approximates the intraluminal cross-sectional profile ofvasculature 201. The substantially conformable character of the firstelongated segment and the second elongated segment to the intraluminalcross section of the vasculature at a cross section proximal to ananeurysm can contribute to the ability of the device to prevent leakage,thus isolating AAA 202 from fluid pressure and promoting more desirableflow characteristics in the treatment region such as un-obstructed flow,reduced pressure change at the treatment region, evenly distributedflow, steady flow or flow that is otherwise consistent with flow througha healthy body lumen.

In these embodiments, first elongated segment 220 can have any suitableshape. Similarly, second elongated segment 230 can have any suitableshape that is complementary to the shape of first elongated segment 220.This complementary arrangement occurs where the combined cross-sectionalprofile of first elongated segment 220 and second elongated segment 230,when installed in vasculature 201, substantially approximates theintraluminal cross-sectional profile of vasculature 201 to minimizeleakage and improve fluid flow characteristics at the treatment site.For example, first end 221 of first elongated segment 220 can have asubstantially elliptical cross-sectional profile when installed at thetreatment region corresponding to proximal lumen 205. First end 231 ofsecond elongated segment 230 can have a suitably complementarysubstantially elliptical cross-sectional profile at the end installed atthe treatment region corresponding to proximal lumen 205, where firstelongated segment 220 and second elongated segment 230 are installedtogether. In this embodiment, each of the first end 221 of the firstelongated segment 220 and the first end 231 of the second elongatedsegment 230 is installed on substantially the same level orcross-sectional plane of the vasculature, though in other embodimentsthey can be installed in other planes or in a longitudinally displacedrelationship. Moreover, because of the complementary shape of the eachof the ends, the combined profile of the ends form a generallyelliptical cross-section that substantially approximates the generallyelliptical cross-section of vasculature 201. The substantialconformation of the first elongated segment 220 and the second elongatedsegment 230 to the intraluminal cross section of proximal lumen 205allows blood and other bodily fluids to flow through the lumens of theelongated segments approximating vasculature 201.

In various embodiments, the first elongated segment and the secondelongated segment can be of any suitable size and shape to provide acombined cross section that is substantially conformable to anintraluminal cross section of a body lumen. The first and secondelongated segments can be of sizes and shapes that are complementary toone another and together provide a combined cross section, such as anellipse, that generally approximates the size and shape of a body lumenand substantially conforms to the intraluminal cross section of a bodylumen when deployed together within the lumen.

For example, and with reference to FIG. 3A, first elongated segment 320and second elongated segment 330 can both have generally ellipticalcross sections that are complementary to one another such that thecombined cross section of the elongated segments substantially conformto the intraluminal cross section of vasculature 301. In various otherembodiments and with reference to FIG. 3B, first elongated segment 320can have a cross-sectional profile that is generally elliptical asillustrated in FIG. 3B, while second elongated segment 330 can a shapethat is complementary to the cross section or a portion of the crosssection of the first elongated segment 320, such as a crescent shapewith an interior arc that complements the elliptical profile of thefirst elongated segment 320. In accordance with various embodiments, thecombined cross-sectional profile of first elongated segment 320 andsecond elongated segment 330 is generally elliptical and approximatesthe intraluminal cross section of vasculature 301 regardless of theindividual cross-sectional profiles of the component elongated segments.

In various embodiments, a device can comprise three or more elongatedsegments. As for the embodiments described above and as illustrated inFIGS. 3C and 3D, the three or more elongated segments can have shapesthat are complementary to one another such that a combined cross sectionof the elongated segments is substantially conformable to anintraluminal cross section of a body lumen such as an ellipse. Forexample, each of first elongated segment 320, second elongated segment330, and third elongated segment 360 can be generally pie-shaped, asillustrated in FIG. 3C. In this configuration, a flat portion of eachpie-shaped profile is configured to abut another flat portion of apie-shaped profile. The curved portion of each pie-shaped profile isconfigured to approximate a portion of vasculature 301. Othercombinations of three or more elongated segments with variouscomplementary cross-sectional profiles, such as a third elongatedsegment 360 with an elliptical cross section combined withcrescent-shaped first elongated segment 320 and second elongated segment330, as illustrated in FIG. 3D, are also within the scope of the presentdisclosure. Any number of elongated segments having any combination ofcross-sectional profiles that, when installed together, form a combinedcross section that is generally elliptical and/or substantially conformsto an intraluminal cross section of a body lumen is within the scope ofthe present disclosure.

In various embodiments, elongated segments of a device can havecross-sectional profiles that are shaped or formed prior to deploymentof the elongated segments, such that the elongated segments take on apredetermined cross-sectional profile upon deployment. For example,elongated segments can be shaped or formed with cross-sectional profilesthat are complementary to each other. The elongated segments can beconstrained to another cross-sectional profile prior to deployment forinsertion and deployment, and upon deployment, the elongated segmentscan take on their predetermined, complementary cross-sectional profilesthat substantially conform to an intraluminal cross section a bodylumen.

In various other embodiments, the cross-sectional profile of anindividual elongated segment can be determined during deployment, suchas by the cross-sectional profile of a balloon expansion device used indeployment. For example, an elongated segment can be plasticallydeformable, such that it can take on and retain the cross-sectionalprofile of the balloon expansion devices used to expand and deploy theelongated segment to the implanted state. Balloon expansion devices canbe used that are capable of expanding an elongated segment to anysuitable size and/or cross-sectional profile, such as circular,elliptical, crescent, pie-shaped or other cross-sectional profiles, suchthat one or more elongated segments are complementary to one another andsubstantially conform to the intraluminal cross section of the bodylumen in which they are deployed.

In accordance with still other embodiments, the elongated segments canbe flexible such that they can accommodate a broad range ofcross-sectional profiles and conform in their individual cross-sectionalprofiles to the intraluminal cross section of the body lumen in whichthey are deployed. In these embodiments, the intraluminal cross sectionof the body lumen in which an elongated segment is deployed may bedetermined by another elongated segment and/or other medical device,either temporary or implanted, during deployment of the flexibleelongated segment in the body lumen. Stated differently, the flexibleelongated segment may generally lack a predetermined deployedcross-sectional profile, and the cross-sectional profile of the flexibleelongated segment is determined by the cross-sectional profile of thebody lumen in which it is deployed and any other elongated segments ormedical devices that may be deployed therein, regardless of thecross-sectional profile of the body lumen or of those elongated segmentsor medical devices within the body lumen.

In accordance with various embodiments, one of the elongated segmentsmay have the property of being flexibly able to adapt to thecross-sectional profile of the lumen in which it is located. In variousother embodiments, more than one of the elongated segments may be soflexibly adaptable. For example, in a case where two flexibly adaptableelongated segments are deployed together in a body lumen, the twoelongated segments would together substantially conform to one anotherand to the intraluminal cross section of the body lumen in which theyare located. In such an embodiment, predetermined complementarycross-sectional profiles for the elongated segments are not required.These embodiments may provide advantages such as the ability toindependently position an elongated segment longitudinally and/orrotationally. For example, the absence of predetermined complementarityof one elongated segment with a second elongated segment eliminates therequirement that the two complementary elongated segments be alignedlongitudinally and rotationally so as to provide the plannedcomplementary cross-sectional profile.

In accordance with any of the various embodiments described herein, theelongated segments might only be substantially conformable to theintraluminal cross section of a body lumen where there are two or moreelongated segments present in the intraluminal cross section of the bodylumen. Stated differently, a device in accordance with variousembodiments may or may not substantially conform to the intraluminalcross section of a body lumen in cross sections in which only a singleelongated segment is located. For example, a device in accordance withvarious embodiments can comprise two elongated segments of the samelength but that are longitudinally displaced from one another within thebody lumen, such that only one elongated segment is located at variouscross sections within the body lumen. In this example, at theintraluminal cross section(s) of the body lumen that is occupied by asingle elongated segment, the elongated segment may not substantiallyconform to the intraluminal cross section of the body lumen but may onlypartially occupy the intraluminal cross section.

In accordance with various embodiments, an elongated segment cancomprise an open stent region. An elongated segment can comprise an openstent region in any portion of the elongated segment. An open stentregion of an elongated segment is a portion of an elongated segmentcomprising support elements but lacking a covering material or otherwisehaving a configuration that is perfusable by a fluid. An open stentregion of an elongated segment can be located at any part of anelongated segment and can comprise any portion of the elongated segment.For example, an open stent region can be located at an end of anelongated segment or anywhere along the length of the elongated segment.The open stent portion can include the entire circumference of a portionof the length of an elongated segment, or can comprise a portion of thecircumference and the length of the elongated segment, forming an openstent window in an area of the elongated segment.

In various embodiments and with reference to FIG. 4 , first elongatedsegment 420 comprising subsegments 420 a and 420 b and second elongatedsegment 430 comprising subsegments 420 a and 420 b can also compriseopen stent regions 426 and 436 at first end 421 and first end 431,respectively. As illustrated in FIG. 4 , open stent regions 426 and 436may be located in a region of the elongated segments such that the openregion may permit perfusion of branch arteries of the vasculature 401when deployed. For example, in vasculature, open stent regions 426 and436 may permit perfusion of the SMA and celiac arteries (not shown)located proximally to renal arteries 410.

In accordance with various embodiments described above, the elongatedsegments or subsegments of a device may be self-expanding or may beexpanded during deployment by a deployment device such as a balloonexpansion device. The elongated segments or subsegments thereof may beself-expanding or balloon-expandable to predetermined cross-sectionalprofiles. The elongated segments or subsegments may also be balloonexpandable to cross-sectional profiles conferred by balloon expansiondevices having any of a variety of possible cross-sectional profiles. Invarious embodiments, the elongated segments may be self-expanding orballoon expandable such that they take on the cross-sectional profile ofthe lumen in which they are located.

In accordance with various embodiments, a device may also comprisebranch segments. A branch segment may be engaged to an opening in theside of one of the elongated segments, and the branch segment mayfurther define a branch lumen in fluid communication with one of theprimary lumens of the device. A device in accordance with variousembodiments may have one branch segment. In various other embodiments, adevice may have two or more branch segments. In various embodiments, asingle elongated segment may be engaged to two or more branch segments.In other embodiments, one elongated segment may be engaged to one ormore branch segments while a second elongated segment is also engaged toone or more branch segments. In accordance with various embodiments andreferring again to FIG. 2 , the illustrated device comprises four branchsegments, with first elongated segment 220 and second elongated segment230 of the device each having two branch segments. First branch segment223 is engaged to subsegment 220 a of elongated segment 220, and secondbranch segment 224 is engaged to subsegment 220 b of elongated segment220. Third branch segment 233 is engaged to subsegment 230 a ofelongated segment 230, and fourth branch segment 234 is engaged tosubsegment 230 b of elongated segment 230. A device comprising anynumber of elongated segments, each comprised of any number ofsubsegments and engaged to any number of branch segments, is within thescope of the present disclosure.

In various embodiments, a branch segment may be engaged to an elongatedsegment as an integral component of the elongated segment. For example,the branch segment may be integrally or permanently engaged to anelongated segment or a subsegment thereof by the support structureand/or the covering material during construction of the elongatedsegment. FIG. 5B illustrates an elongated segment 540 with a permanentlyengaged branch segment 543 in accordance with various embodiments. Inthese embodiments, the support structure of the branch segment may becontinuous with the support structure of the elongated segment to whichthe branch segment is attached, or the support structure of the branchsegment may be otherwise permanently engaged to the support structure ofthe elongated segment, such as by welding, brazing, bonding, wiring,tying, or any other manner of attaching one support structure to anothersupport structure. In various other embodiments, a branch segment may bepermanently engaged to an elongated segment or a subsegment thereof bythe covering material. For example, the covering material may be formedon a mandrel whose shape defines an elongated segment and an attachedbranch segment, such that the resultant formed covering materialcomprises a branch segment defined by covering material that isintegrally connected with the covering material defining the elongatedsegment. In various embodiments, a branch segment may be permanentlyengaged to an elongated segment by any combination of permanently orintegrally connected support structure or covering material.

In accordance with other embodiments, a branch segment can be engaged toan elongated segment in a modular fashion after separate construction ofan elongated segment and a branch segment. FIGS. 6A and 6B illustrate anelongated segment 640 with a branch segment 643 that is modularlyengaged. In such an embodiment, a side branch opening or fenestration645 can be created in the covering material and/or support element ofelongated segment 640, and branch segment 643 can be engaged toelongated segment 640 at the location of fenestration 645 such that thelumen of branch segment 643 is in fluid communication with the lumen ofelongated segment 640. In accordance with various embodiments, thebranch segment can be engaged to the elongated segment prior todeployment of the device, or the branch segment can be engaged to theelongated segment in situ in the treatment region. The branch segmentcan be engaged by insertion through the fenestration, for example, byinserting the branch segment into and through the fenestration followedby radial expansion of the branch segment such that an outer surface ofthe branch segment approximates and seals against the perimeter of thefenestration. In various embodiments, a branch segment can be engaged toan elongated segment by insertion through an internal branch supportassociated with a fenestration. An internal branch support can comprise,for example, an internal branch channel in the interior of an elongatedsegment. In such embodiments, a branch segment can be inserted throughan internal branch support and an associated fenestration from eitherthe interior of the elongated segment or from the exterior of theelongated segment. Alternatively, the branch segment can be engaged tothe perimeter of the fenestration at an end of the branch segment, withthe circumference of the end of the branch segment engaged to theperimeter of the fenestration in the elongated segment via connectingmeans such as by anchoring with hooks, barbs, or any other device ormechanism suitable for attachment of a stent or stent-graft to anotherstent or stent-graft. In accordance with various embodiments, additionalmeasures can be taken to reinforce the engagement of the branch segmentto the elongated region in such an embodiment using any appropriatemethod and material.

In accordance with various embodiments and regardless of whether abranch segment is permanently or modularly engaged to an elongatedsegment, the branch segment is engaged to the elongated segment in sucha manner that the engagement is substantially fluid-tight. A fluid-tightengagement in accordance with various embodiments can prevent endoleaksand enable a device to provide for the isolation of a treatment regionhaving branch vessels from fluid pressure.

In accordance with various embodiments, a branch segment can be engagedto an elongated segment in a manner that allows the elongated segmentand the branch segment to be inserted into a body lumen. In variousembodiments and as illustrated in FIG. 5A, branch segment 543 can bepositioned against and/or alongside the elongated segment 540 to whichit is attached or otherwise constrained along with the elongated segmentso that the elongated segment and the branch segment together have asize and conformation that is suitable for insertion into a body lumen,regardless of whether the branch segment is permanently or modularlyengaged to the elongated segment.

In accordance with various embodiments, a branch segment is suitable fordeployment in a branch vessel. The capacity for the branch segment to beconstrained for insertion may be a function of the properties of thebranch segment, the manner in which the branch segment is engaged to theelongated segment, the elongated segment, or any combination of thesefactors. For example, for devices in which the branch segment ispermanently engaged to the elongated segment by the covering material,the region in which the branch segment is engaged to the elongatedsegment may be free of support structures such that the branch segmentis free to articulate on a longitudinal axis of the branch segmentrelative to the longitudinal axis of the elongated segment to which itis engaged. In other embodiments, the support structure of the elongatedsegment in the area adjacent to where a branch segment is engaged or thesupport structure by which the branch segment is engaged to theelongated segment can have a configuration that similarly provides foror allows the branch segment to articulate relative to the elongatedsegment in a manner that facilitates insertion of the device into thebody in a constrained form. Any configuration or manner of constructionor engagement of the branch segment, the elongated segment, or both,that permits the device to be constrained for insertion into a bodylumen is within the scope of the present disclosure.

Likewise, a branch segment can be engaged to an elongated segment in anyof a range of possible orientations in accordance with variousembodiments. For example, a branch segment may be engaged to anelongated segment such that the longitudinal axis of the branch segmentis perpendicular to the longitudinal axis of an elongated segment towhich it is engaged. Alternatively, the branch segment can be engagedsuch that the longitudinal axis of the branch segment is at any anglewith respect to the longitudinal axis of an elongated segment. Invarious embodiments, a branch segment can be curved in the region inwhich it engages an elongated segment. Any configuration of anintersection by which a branch segment can engage an elongated segmentis within the scope of the present disclosure.

In accordance with various embodiments, a branch segment can assistanchoring of an elongated segment. Deployment of a branch segment in abranch vessel can prevent or assist the prevention of migration orslippage of the elongated segment from its implanted position in thebody lumen. A branch segment can also facilitate approximation andsealing of a peripheral surface of the elongated segment with anadjacent interior wall of the body lumen.

In accordance with various embodiments, a device can comprise anchors.The anchors can be any structure capable of engaging an adjacent objectsuch as the wall of a vessel or other body lumen or an adjacent medicaldevice or device component. The anchors can be deployed to maintain theimplanted position of the device in the body after the device has beendeployed. The anchors can further serve to maintain the positions of twoor more elongated segments of a device with respect to one another andtheir positions within the vasculature, such as the respectivelongitudinal positions of two elongated segments. Anchors mayadditionally facilitate approximation of the peripheral surfaces of theelongated segments against adjacent surfaces to seal the peripheralsurfaces against the adjacent surfaces and prevent fluid leakage intogutters between elongated segments or between an elongated segment andthe adjacent vessel wall.

In accordance with various embodiments, an anchor can comprise a branch,as described above, or a hook, barb, or other similar structure. Theanchor can be deployed together with deployment of the elongated segmentor in a deployment step that is separate from the elongated segmentcomprising the anchor. For example, in an elongated segment that isdeployed by radial expansion using a balloon expansion device, theanchor may deploy simultaneously with radial expansion and deployment ofthe portion of the elongated segment comprising the anchor.

In accordance with other embodiments, the anchor can be deployedseparately from radial expansion of the portion of the device comprisingthe anchor. In various embodiments, the anchor can be deployed prior todeployment of the elongated segment or following deployment of theelongated segment. Any type of anchor at any location on an elongatedsegment, deployed in any manner or at any stage of deployment of thedevice, is within the scope of the present disclosure.

In various embodiments, a device may comprise connectors. In accordancewith various embodiments, the connectors facilitate sealing of thedevice within a body lumen. The connectors can be configured to maintainat least a portion of an outer surface of one of the first elongatedsegment and the second elongated segment in proximity with an adjacentperipheral surface so as to reduce fluid flow into an area between theouter surface and the adjacent peripheral surface. An outer surface ofan elongated segment can be the peripheral or extraluminal surface ofthe elongated segment at an end of the elongated segment, or it can be aperipheral surface anywhere along the length of the elongated segment.In accordance with various embodiments, sealing along an outer surfaceof an elongated segment is desirable to prevent fluid leakage betweenadjacent elongated segments and/or between an elongated segment and theadjacent vessel or body lumen wall and to thus isolate a treated regionof a body lumen, such as an aneurysm of the vasculature, from fluidpressure. In accordance with various embodiments, an elongated segmentcomprises connectors that can be structures such as anchors,articulating flanges, or flaps that function to provide a seal or tocontribute to or enhance the capacity of an elongated segment to providea seal when deployed.

In various embodiments, structures that can function as anchors, asdescribed above, can also serve as connectors, and vice versa, and asingle structure or type of structure may serve as both an anchor and aconnector.

In various embodiments, the first end of a first elongated segment andthe first end of a second elongated segment can be configured withconnectors that engage with each other when the elongated segments areimplanted in the treatment region. First elongated segment and secondelongated segment can each be configured with a suitable connector suchas, for example, hooks or barbs. These connectors can be configured tooperatively engage one another upon deployment such that the first endof first elongated segment and the first end of second elongated segmentare connected together.

In accordance with various other embodiments, an end of a firstelongated segment is configured with a connector for associating aportion of the circumference of the elongated segment at an end of theelongated segment with an adjacent peripheral surface. The connector mayoperatively engage a peripheral surface of a second elongated segment ata position located along the length of the second elongated segmentrather than at an end of the second elongated segment. Likewise, theconnector may operatively engage an inner surface of the body lumen inwhich first elongated segment is deployed. In accordance with variousembodiments, the connector can serve as an anchor for maintaining therelative position of the device within the body lumen on a longitudinalbasis, and/or the connector can serve to approximate a section of thecircumference of the device with an adjacent peripheral surface so as tominimize fluid leakage through an area between the device and theadjacent peripheral surface, regardless of whether the adjacentperipheral surface comprises a medical device or the inner surface ofthe body lumen.

In various embodiments, an elongated segment can comprise a connectorconsisting of articulating flange segments. FIGS. 7A and 7B illustratean elongated segment 740 having flange segments 746 in accordance withvarious embodiments. Articulating flange segments 746 can be attached toelongated segment 740 at an end of the elongated segment or they can beattached on or near the extraluminal surface of the elongated segment.The articulating flange segments 746 can be configured to articulate orotherwise extend outwardly from a longitudinal axis of the elongatedsegment along at least a portion of the outer surface of the elongatedsegment, such as a portion of the circumference of the elongated segmentat its end.

In various embodiments, the articulating flange segments may comprisesupport elements and covering material. For example, the articulatingflange segments can comprise a series of individual sections of coveringmaterial extending from an end of the elongated segments. Eachindividual section can further include a support element. The coveringmaterial and/or support elements of the articulating flange segments canbe comprised of covering material and/or support elements that arecontinuous with and/or an extension of the covering material and/orsupport element of the elongated segment. In other embodiments, thearticulating flange segments can be comprised of covering materialand/or support elements that are separate and/or different from those ofelongated segment, and the articulating flange segments can be modularlyor permanently attached to the elongated segment.

In various embodiments, each articulating flange segment comprises ashape that has a surface area. Each articulating flange segment may besubstantially planar. The primary plane defined by a flange segment canbe generally perpendicular to radius from a longitudinal axis of theelongated segment. Each flange segment can have any of a variety ofshapes, including, for example, square, rectangular, triangular,semicircular, or any other geometric or non-geometric, irregular shape.In various embodiments, at least a portion of one edge of the shapecomprised by a flange segment is the edge along which the flange segmentis attached to the elongated segment.

In accordance with various embodiments, each individual articulatingflange segment can be separate from each other articulating flangesegment. Although each flange segment may be separate, a portion of thesurface area of each articulating flange segment may overlap with aportion of the surface area of each adjacent articulating flangesegment. In accordance with other embodiments, an articulating flangesegment can be connected to another articulating flange segment, forexample, by covering material and/or by a support element.

In accordance with various embodiments, each flange segment isconfigured to extend outwardly from a longitudinal axis of an elongatedsegment. A flange segment can extend outwardly from a longitudinal axisof the elongated segment by articulating, for example, at a joint orother region configured to bend. Such outward articulation caneffectively increase the cross-sectional area of the elongated segmentand facilitate sealing of the elongated segment against an adjacentperipheral surface such as an adjacent elongated segment or an interiorsurface of a vessel wall. In various embodiments, the flange segmentscan be configured to articulate by deforming, such as by bending,pivoting or otherwise changing in shape or conformation with respect tothe elongated segment. For example, flange segments attached to the endof an elongated segment may be deformed by a balloon expansion deviceduring or following deployment of the elongated segment, such that theflange segments approximate adjacent peripheral surfaces and theelongated segment substantially conforms to the intraluminal crosssection of the body lumen in which it is implanted. The flange segmentsmay articulate at any portion of the flange segment, for example, at ajunction of a flange segment with an elongated segment or anywhere alonga length of a flange segment. In various embodiments, the flangesegments may comprise anchors such as hooks or barbs to assist withmaintaining the position of the flange segments adjacent to peripheralsurfaces.

In various embodiments, an elongated segment may comprise a connectorthat consists of a flap. In accordance with various embodiments and asillustrated in FIG. 8A, elongated segment 840 can have a flap 847 thatextends from a portion of end 841 of elongated segment 840. Flap 847 cancomprise a section of covering material that extends beyond end 841 ofelongated segment 840. Flap 847 comprising covering material may or maynot further comprise support elements. In various embodiments, a flaphas a thickness that is substantially similar to or the same as thethickness of the covering material of the elongated segment. Thecovering material comprising a flap can be continuous with the coveringmaterial of the elongated segment, or the covering material can be aseparate and/or different covering material that may be permanently ormodularly engaged to the covering material of the elongated segment. Thecovering material of a flap can be the same material as the coveringmaterial of the elongated segment, or a flap can be comprised of adifferent material.

In various embodiments, flap 847 may have a width that is a fraction ofthe circumference of the end of the elongated segment to which it isattached. For example, the flap can have a width that is one third, orone quarter, or one fifth of circumference of the end of the elongatedsegment. The denominator of the fraction need not be an integer; thewidth of the flap can be any suitable proportion of the circumference ofthe end of the elongated segment. The flap also has a length. The lengthof the flap can be any suitable length that allows the flap of coveringmaterial to extend or fold outwardly from a longitudinal axis of theelongated segment and to wrap around and into the lumen of an adjacentelongated segment.

In various embodiments and as illustrated in FIGS. 8A-8D, the width, thelength, and the shape of flap 847 is such that the width of the flap cancover a substantial portion of the distance along which a peripheralsurface of the end 841 of first elongated segment 840 to which flap 847is attached and a peripheral surface of end 851 of adjacent elongatedsegment 850 are adjacent to one another. Likewise, the length of flap847 is such that the flap can extend into the lumen of adjacentelongated segment 850 and be located adjacent to an intraluminal surfaceof adjacent elongated segment 850. In this manner, a flap in accordancewith various embodiments can occlude or seal an area between elongatedsegment 840 and adjacent elongated segment 850, thus contributing topreventing leakage between the two elongated segments.

In accordance with various embodiments, a branch segment is configuredto be substantially conformable to an intraluminal cross section of abranch vessel lumen in any manner previously described herein withrespect to elongated segments. Likewise, a branch segment in accordancewith various embodiments can also comprise anchors, connectors, or anyof the various other features described herein with respect to elongatedsegments or devices in general.

The devices, support structures, coatings, and covers, described above,can be biocompatible. As used herein, “biocompatible” means suited forand meeting the purpose and requirements of a medical device, used foreither long or short term implants or for non-implantable applications.Long term implants are defined as items implanted for more than 30 days.These support structures, coatings, and secondary structures may beformed of a fluoropolymer such as ePTFE. Alternatively, or incombination with a fluoropolymer, the support structures, coatings, andsecondary structures may be formed of biocompatible materials, such aspolymers, which may include fillers such as metals, carbon fibers,Dacron, glass fibers or ceramics. Such polymers may include olefinpolymers, polyethylene, polypropylene, polyvinyl chloride,polytetrafluoroethylene which is not expanded, fluorinated ethylenepropylene 45 copolymer, polyvinyl acetate, polystyrene, poly(ethyleneterephthalate), naphthalene dicarboxylate derivatives, such aspolyethylene naphthalate, polybutylene naphthalate, polytrim ethylenenaphthalate and trim ethylenediol naphthalate, polyurethane, polyurea,silicone rubbers, polyam ides, polycarbonates, polyaldehydes, naturalrubbers, polyester copolymers, styrene-butadiene copolymers, polyethers,such as fully or partially halogenated polyethers, copolymers, andcombinations thereof. Also, polyesters, including polyethyleneterephthalate (PET) polyesters, polypropylenes, polyethylenes,polyurethanes, polyolefins, polyvinyls, polymethylacetates, polyamides,naphthalane dicarboxylene derivatives, and natural silk may be includedin support structures, coatings and secondary structures.

These support structures, covers, and coatings may be utilized withbio-active agents. Bio-active agents can be coated onto a portion or theentirety of the support structures, coatings and secondary structuresfor controlled release of the agents once the support structures,coatings and secondary structures is implanted. The bio-active agentscan include, but are not limited to, vasodilator, anti-coagulants, suchas, for example, warfarin and heparin. Other bio-active agents can alsoinclude, but are not limited to agents such as, for example,anti-proliferative/antimitotic agents including natural products such asvinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine),paclitaxel, epidipodophyllotoxins (i.e. etoposide, teniposide),antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin andidarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin(mithramycin) and mitomycin, enzymes (L-asparaginase which systemicallymetabolizes L-asparagine and deprives cells which do not have thecapacity to synthesize their own asparagine); antiplatelet agents suchas G(GP) IIb/IIIa inhibitors and vitronectin receptor antagonists;anti-proliferative/antimitotic alkylating agents such as nitrogenmustards (mechlorethamine, cyclophosphamide and analogs, melphalan,chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine andthiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine (BCNU)and analogs, streptozocin), trazenes-dacarbazinine (DTIC);anti-proliferative/antimitotic antimetabolites such as folic acidanalogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine,and cytarabine), purine analogs and related inhibitors (mercaptopurine,thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine});platinum coordination complexes (cisplatin, carboplatin), procarbazine,hydroxyurea, mitotane, aminoglutethimide; hormones (i.e. estrogen);anti-coagulants (heparin, synthetic heparin salts and other inhibitorsof thrombin); fibrinolytic agents (such as tissue plasminogen activator,streptokinase and urokinase), aspirin, dipyridamole, ticlopidine,clopidogrel, abciximab; antimigratory; antisecretory (breveldin);anti-inflammatory: such as adrenocortical steroids (cortisol, cortisone,fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone,triamcinolone, betamethasone, and dexamethasone), non-steroidal agents(salicylic acid derivatives i.e. aspirin; para-aminophenol derivativesi.e. acetaminophen; indole and indene acetic acids (indomethacin,sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac,and ketorolac), arylpropionic acids (ibuprofen and derivatives),anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids(piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone),nabumetone, gold compounds (auranofin, aurothioglucose, gold sodiumthiomalate); immunosuppressives: (cyclosporine, tacrolimus (FK-506),sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenicagents: vascular endothelial growth factor (VEGF), fibroblast growthfactor (FGF); angiotensin receptor blockers; nitric oxide donors;anti-sense oligonucleotides and combinations thereof; cell cycleinhibitors, mTOR inhibitors, and growth factor receptor signaltransduction kinase inhibitors; retinoids; cyclin/CDK inhibitors; HMGco-enzyme reductase inhibitors (statins); and protease inhibitors.

In accordance with various embodiments, the elongated segments of adevice can be positioned within a treatment region independently of oneanother. Independent positioning of the elongated segments of a devicemay comprise separate placement of elongated segments of a device in anyof a number of combinations with respect to one another, and positioningand/or repositioning of an individual elongated segment may include allmanner of possible motions and/or movements, as previously definedherein. Any reference to independent positioning of an elongated segmentcan also refer to independent positioning of individual subsegments ofan elongated segment. Furthermore, individual subsegments of anelongated segment may be positioned independently of one another in anymanner described herein with reference to elongated segments. Suchindependent positioning of components of a device in accordance withvarious embodiments can be accomplished without sacrificing ornegatively affecting other characteristics of the device or its capacityto perform an intended function, for example, the ability of the deviceto substantially conform to an intraluminal cross section of the bodylumen and isolate a treatment region from fluid pressure.

For example and as illustrated in FIG. 9A, for a device comprising twoelongated segments, first elongated segment 920 comprising subsegments920 a and 920 b can be positioned and implanted in a longitudinallydisplaced configuration in the treated vasculature 901 with respect tosecond elongated segment 930 comprising subsegments 930 a and 930 b(i.e., the first end 921 and first end 931 and/or the second end 922 andsecond end 932 of the first and second elongated segments may not belocated at the same longitudinal position within a treated vessel). Insuch an example and as will be described in additional detail herein,both first elongated segment 920 and second elongated segment 930 can beinserted into and co-occupy various transverse sections of thevasculature 901, and one of the elongated segments can be deployed to anexpanded state, while both elongated segments retaining the capacity tobe independently positionable, as described herein, without the need forrecapture of the deployed elongated segment prior to independentpositioning of either device component.

In accordance with various embodiments, the capacity of the elongatedsegments of the device or system to be independently positionablelongitudinally may facilitate the ability of the device to conform toirregular vasculature such as the abdominal aorta illustrated in FIG. 9Adepicting angulation of the infrarenal aortic neck. For example, firstelongated segment 920 may be located on the inside curve or angle of anangulated infrarenal aortic neck 904 and have one longitudinal positionwithin the aorta to facilitate proximal attachment of the elongatedsegment and placement of branch segment 923 in one renal artery 910.Second elongated segment 930 may be located on the outside curve orangle of the angulated infrarenal aortic neck 904 and have a differentlongitudinal position within the aorta relative to first elongatedsegment 920, with the differential longitudinal position being necessaryor convenient for optimal proximal attachment of the second elongatedsegment and placement of branch segment 933 in the other renal artery910.

In accordance with various embodiments and as illustrated in FIGS.9A-9C, the first and second elongated segments in an longitudinallydisplaced arrangement may still co-occupy at least one cross section ofthe aorta proximal to the aneurysm and substantially conform to theintraluminal cross section of the aorta at that cross section,effectively isolating the aneurysm from fluid pressure at the proximalend in a manner that is adaptable to an angulated infrarenal aortic neck904. For example and with reference to FIGS. 9A and 9B, first end 921 offirst elongated segment 920 may be longitudinally displaced from firstend 931 of second elongated segment 930 such that first end 921 of firstelongated segment 920 partially occupies an intraluminal cross sectionof vasculature 901. With reference to FIGS. 9A and 9C, at a more distalcross section of vasculature 901 through angulated infrarenal aorticneck 904, both first elongated segment 920 and second elongated segment930 occupy and substantially conform to the intraluminal cross sectionof the vasculature.

In other examples in accordance with various embodiments of the presentdisclosure, a longitudinally displaced arrangement of elongated segmentscan be used to accommodate severe angulation of the aorta proximal tothe aneurysm or treatment regions wherein branch arteries such as therenal arteries are located immediately adjacent to or within the regionof the aortic aneurysm, such as in a juxtarenal or a suprarenal aorticaneurysm. In accordance with various embodiments, a first elongatedsegment and a second elongated segment may substantially conform to anintraluminal cross section of an abdominal aorta at a cross section thatis proximal to the renal arteries (i.e., suprarenal). In variousembodiments, the elongated segments used in such applications maycomprise branch segments. Branch segments in accordance with variousembodiments can be deployed in a branch vessel such as a renal arteryand attach to a side opening of an elongated segment such that a branchlumen of the branch segment is in fluid communication with the lumen ofthe elongated segment. In such embodiments, the branch segment isengaged to the elongated segment in a manner that maintains fluidcommunication between a proximal region of the aorta and the branchvessel while preventing fluid leakage at the site of engagement,notwithstanding the pararenal location of the aneurysm.

In accordance with various embodiments, elongated segments or portionsthereof may be independently positionable with respect to anotherelongated segment. In various embodiments, in addition to independentlongitudinal positioning, an elongated segment may be moved laterally(i.e., to a different radial position within a body lumen),rotationally, torsionally, or angularly, or may be moved and positionedusing any combination of the aforementioned categories of movement. Forexample, an elongated segment may be rotated about a predominantlylongitudinal axis independently of another elongated segment to orient abranch segment with a branch vessel or to orient a portion of thecross-sectional profile of the elongated segment with a complementaryelongated segment. Likewise, an elongated segment may be moved tovarious radial positions within a body lumen, for example, from a moreanterior position within a body lumen to a more lateral position withina body lumen.

Similarly, the angle of an elongated segment or a portion of anelongated segment may be changed within a body lumen independently ofanother elongated segment. For example, the angle of an elongatedsegment or a section thereof, such as an end, may be changed such that alongitudinal axis of an elongated segment or a portion thereof is skewedwith respect to a longitudinal axis of a body lumen or a portionthereof. A capacity of the separate elongated segments of a device forindependent positioning using any type of movement in any possibledirection is within the scope of the present disclosure. Independentmovement and positioning of elongated segments of a device such as thatdescribed herein facilitates adaptation of the components of a device toany given anatomical configuration of a treatment site so that thecombined cross section of the elongated segments of a device maysubstantially conform to an intraluminal cross section of a body lumen.Independent movement and positioning may further facilitate placement ofbranch segments within branch vessels and optimal flow of fluid througha vessel and associated branch vessels without endoleaks in a mannerthat approximates a normally functioning, intact vasculature.

In various embodiments, a device may be deployed using any suitabledevice delivery system. The device delivery system may comprise one ormore catheters, guidewires, or other suitable conduit for delivering anelongated segment to a treatment region. In these embodiments, thecatheters, guidewires, or conduits may comprise lumens configured toreceive inputs and/or materials from the proximal end of the medicaldevice delivery system and conduct the inputs and/or materials to theelongated segment at the treatment region.

In various embodiments, various components of the devices disclosedherein are steerable. For example, during deployment at a treatmentsite, one or more of the elongated segments may be configured with aremovable steering system that allows an end of the elongated segment tobe biased or directed by a user. A removable steering system inaccordance with various embodiments can facilitate independentpositioning of an elongated segment and may provide for the ability of auser to accomplish any of the types of movements previously described,such as longitudinal movement, lateral movement, rotational movement, orangular movement.

In accordance with various embodiments, a method of installing animplantable medical device into the body of a patient comprisesdeploying two or more elongated segments in a target region of thevasculature. In various embodiments, a method of installing animplantable medical device further comprises deploying a branch segmentin a branch vessel.

In various embodiments, a method of installing an implantable medicaldevice in the body of a patient comprises deploying a first elongatedsegment from a first elongated segment constrained state to a firstelongated segment implanted state in a target region of the vasculatureand deploying a second elongated segment from a second elongated segmentconstrained state to a second elongated segment implanted state in thetarget region of the vasculature. In accordance with variousembodiments, the first elongated segments and the second elongatedsegments are substantially parallel to one another in at least a portionof the target region of the vasculature. Substantially parallel inaccordance with various embodiments means generally aligned with eachother within a vasculature or within a portion of the vasculature.Elongated segments that may have divergent longitudinal axes at anygiven cross section are nonetheless within the scope of the presentdisclosure. In accordance with various embodiments, deploying anelongated segment may comprise deploying and joining two or moresubsegments. Subsegments can be separately inserted and deployed, withthe subsegments being joined together during subsegment deployment, andthe entire process comprising deployment of an elongated segment.

In various embodiments, a method of installing an implantable medicaldevice into the body of a patient comprises deploying a branch segmentinto a branch vessel. A branch segment lumen of the branch segment inaccordance with various embodiments is in fluid communication with aprimary lumen of one of the first and second elongated segments. Invarious embodiments, deploying a branch segment may comprise deploying aconstrained branch segment from a constrained state to an implantedstate within a branch vessel.

In accordance with various embodiments, deploying a branch segment maycomprise attaching a branch segment to one of the first elongatedsegment and the second elongated segment. A branch segment may beattached to an elongated segment by inserting a branch segment into aside opening of one of the elongated segments or by engaging the end ofa branch segment to the side opening of the elongated segment. Deployinga branch segment may further comprise inserting a branch segment into aninternal branch support of the elongated segment. Insertion of a branchsegment into an internal branch support may be done from within thelumen of the elongated segment or from the outside of the elongatedsegment to which the branch segment is engaged. Furthermore, deploymentof a branch segment in accordance with various embodiments may comprisecreation of a side opening in and/or engagement of a branch segment withan elongated segment, regardless of whether the elongated segment is inthe constrained or implanted state, following insertion of the elongatedsegment into the target region of the vasculature.

In various embodiments, installing an implantable medical device intothe body of a patient may comprise deploying at least two branchsegments. In accordance with various embodiments, installing a medicaldevice can comprise deploying a first elongated segment having at leasttwo branch segments or deploying a first elongated segment and a secondelongated segment, each elongated segment having at least one branchsegment.

In various embodiments, deploying a branch segment into a branch lumencomprises deploying one or more branch segments into one or more branchvessels. Branch vessels in accordance with various embodiments caninclude, for example, renal arteries, internal iliac arteries, theceliac artery, or the SMA. Any other branch vessel of a vasculature orany other body lumen is within the scope of the present disclosure.

In accordance with various embodiments, installing an implantablemedical device can comprise repositioning an elongated segment. Invarious embodiments, an elongated segment can be repositioned afterdeployment of the elongated segment to the target region without theneed to reconstrain the elongated segment after deployment. For example,during deployment of a medical device comprising two or more elongatedsegments, one of the elongated segments can be inserted into the targetregion of the vasculature and deployed from a constrained state to anelongated state such as a radially expanded state. In such an example,the deployed elongated segment can be repositioned, such as by movingthe proximal end of the elongated segment to a lower level (i.e., a moredistal position within the vasculature), without reconstraining theelongated segment. Repositioning without reconstraining may be performedregardless of whether another elongated segment has been inserted intothe target region. For example, an elongated segment may be deployed toan implanted state in a target region of the vasculature andrepositioned before another elongated segment has been inserted, ordeployment and repositioning may be performed after insertion but priorto deployment of another elongated segment.

In various embodiments, installing an implantable medical device maycomprise positioning an open stent region of an elongated segmentadjacent to an opening of a branch vessel. In accordance with variousembodiments, a portion of an elongated segment, for example, a proximalor first end, can comprise an open stent region with a support elementlacking a covering material. A method of installing an implantablemedical device comprising an open stent region can include positioningthe elongated segment such that the open stent region is adjacent to andallows perfusion of an opening of a branch vessel, such as a celiacartery or a SMA. An elongated segment can comprise an open stent regionat any portion of the elongated segment, and positioning of the openstent region of an elongated segment can comprise positioning the openstent adjacent to the opening of any branch vessel of a vasculature.

In various embodiments, installing an implantable medical device cancomprise deploying a connector. In accordance with various embodiments,one of the first elongated segment and the second elongated segmentcomprises a connector for maintaining the position of the elongatedsegment with respect to the vasculature and the other elongated segment.A connector can comprise a hook, barb, or any other structure foroperationally engaging a portion of an elongated segment with anadjacent structure, such as an interior surface of the vasculature or anexterior surface or connector of another elongated segment. In variousembodiments, a method of installing a medical device can comprisedeploying a connector simultaneously with deployment of the elongatedsegment to an implanted state. In other embodiments, deployment of aconnector may occur separately from deployment of the elongated segment,including deployment of the connector either before or after deploymentof the elongated segment to an implanted state.

In accordance with various embodiments, any logical order of any of theabove described aspects of a method of installing an implantable medicaldevice is within the scope of the present disclosure. For example, twoor more elongated segments may be inserted and/or deployed in a targetregion of a vasculature prior to deploying a branch segment in a branchvessel. Alternately, a first elongated segment and at least one branchsegment may be deployed prior to insertion and/or deployment of a secondelongated segment. Any possible permutation of insertion and/ordeployment of two or more elongated segments in a target region of avasculature, including any possible permutation of deploying at leastone branch segment in a branch vessel of the target region, is withinthe scope of the present disclosure. Likewise, any possible permutationof additional steps such as repositioning an elongated segment,positioning an open stent region, and/or deploying a connector alongwith the steps of deploying elongated segments and/or branch segments isalso within the scope of the present disclosure. Any presented order ofmethod steps is intended for illustrative purposes only and not by wayof limitation.

The devices and methods described herein may provide benefits such asmodularity that enable various individual device components to beselected and installed together at a treatment site and increase theability of a physician to adaptably treat an increased range ofanatomical variation. Devices in accordance with the present disclosurepermit sizing and configuration of elongated segment and/or branchsegment components that can conform to the specific geometry of thevasculature at a treatment site.

The devices and methods disclosed herein can provide the physician witha broader range of treatment options as compared to selecting from alimited range of predetermined options. For example, a device inaccordance with various embodiments can comprise two elongated segmentsselected by the physician to provide a combined cross section suitableto approximate the cross section of a vasculature at a treatment site ofa patient, and the device may further comprise branch segments that maybe added to the elongated segments in a fashion that is morecustomizable and adapted to the specific needs and anatomy of thepatient, with the location at which the branch segment is connected tothe elongated segment and the branch segment size determined by thephysician based on the anatomy of the patient and with the branchsegment added to the device in a modular manner.

The modular nature of devices and systems in accordance with the presentdisclosure may confer the benefits as described above while reducing thenumber of separate devices that must be manufactured by a producer orpurchased and stocked by a treating facility. The devices and systems ofthe present disclosed herein may provide the further benefit of reducingthe undeployed sizes or diameters of medical devices and the traumaassociated with insertion and deployment relative to a treatment devicecomprising a single component inserted into the region to be treated.

For the avoidance of doubt, the device and methods disclosed herein havebeen described in the context of providing therapy to the vasculature,however, it should be understood that these devices may be implantablein any suitable body lumen.

Thus, the branched adaptable stent devices and method described hereinprovides a mechanism to substantially approximate various anatomicalconfigurations of the vasculature or other body lumens, including branchvessel lumens, at a treatment region to minimize leakage around themedical device(s) at the treatment region and isolate a treatment regionfrom fluid pressure.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present disclosurewithout departing from the spirit or scope of the disclosure. Thus, itis intended that the present disclosure cover the modifications andvariations of this disclosure provided they come within the scope of theappended claims and their equivalents.

Likewise, numerous characteristics and advantages have been set forth inthe preceding description, including various alternatives together withdetails of the structure and function of the devices and/or methods. Thedisclosure is intended as illustrative only and as such is not intendedto be exhaustive. It will be evident to those skilled in the art thatvarious modifications may be made, especially in matters of structure,materials, elements, components, shape, size and arrangement of partsincluding combinations within the principles of the invention, to thefull extent indicated by the broad, general meaning of the terms inwhich the appended claims are expressed. To the extent that thesevarious modifications do not depart from the spirit and scope of theappended claims, they are intended to be encompassed therein.

What is claimed is:
 1. A device comprising: a first elongated segmenthaving two opposing ends including a first end and a second end ,thefirst elongated segment defining a first primary lumen extending betweenthe first end and the second end and comprising a first subsegment and asecond subsegment, the first and second subsegments being separatelyinsertable into a body lumen and joinable together during subsequentdeployment in the body lumen; a second elongated segment having twoopposing ends including a first end and a second end, the firstelongated segment defining a second primary lumen extending between thefirst end and the second end and comprising a first subsegment and asecond subsegment, the first and second subsegments being separatelyinsertable into the body lumen and joinable together during subsequentdeployment in the body lumen, a combined cross section of the firstelongated segment and second elongated segment being substantiallyconformable to an intraluminal cross section of the body lumen; whereinthe first and second elongated segments can be positioned and implantedin a longitudinally displaced configuration such that the first end ofthe first elongated segment is longitudinally displaced from the firstend of the second elongated segment; and a first branch segment engagedto a first side opening in one of the first and second subsegments ofthe first elongated segment, the first branch segment having a firstbranch lumen in fluid communication with the first primary lumen.
 2. Thedevice of claim 1, wherein a separate cross section of at least one ofthe first elongated segment and the second elongated segmentsubstantially conforms to another elongated segment in the body lumen.3. The device of claim 1, wherein the first branch segment anchors thedevice within the body lumen.
 4. The device of claim 1, wherein thefirst branch segment is engaged to one of the first elongated segmentand the second elongated segment by insertion through a fenestration inone of the first subsegment and the second subsegment.
 5. The device ofclaim 4, wherein the first branch segment is further engaged byinsertion through an internal branch support.
 6. The device of claim 1,wherein the first branch segment is elastically deformable to provide anundeployed device diameter suitable for insertion into the body lumen.7. The device of claim 1, further comprising a second branch segmentattached to a second side opening in one of the first subsegment and thesecond subsegment of the second elongated segment, the second branchsegment having a second branch lumen in fluid communication with thesecond primary lumen.
 8. The device of claim 7, further comprising athird branch segment attached to a third side opening in one of thefirst subsegment and the second subsegment of the first elongatedsegment, the third branch segment having a third branch lumen in fluidcommunication with the first primary lumen.
 9. The device of claim 8,further comprising a fourth branch segment attached to a fourth sideopening in one of the first subsegment and the second subsegment of thesecond elongated segment, the fourth branch segment having a fourthbranch lumen in fluid communication with the second primary lumen. 10.The device of claim 1, further comprising an nth branch segment attachedto an nth side opening in one of the first elongated segment and thesecond elongated segment, the nth branch segment having an nth branchlumen in fluid communication with one of the first primary lumen and thesecond primary lumen.
 11. The device of claim 1, wherein the devicecomprises PTFE, or wherein the device comprises ePTFE, or wherein thedevice comprises an anchor, or wherein the device comprises an openstent region, or wherein the device is reconstrainable.
 12. The deviceof claim 1, wherein the first elongated segment and the second elongatedsegment each have a first end and a second end, and wherein therespective second ends can be displaced from each other within the bodylumen.
 13. The device of claim 1, wherein the device further comprises aconnector configured to maintain at least a portion of an outer surfaceof one of the first elongated segment and the second elongated segmentin proximity to an adjacent peripheral surface so as to reduce fluidflow into an area between the outer surface and the adjacent peripheralsurface.
 14. The device of claim 13, wherein the connector comprises ananchor.
 15. The device of claim 13, wherein the adjacent peripheralsurface comprises an end of one of the first elongated segment and thesecond elongated segment.
 16. An implantable endovascular systemcomprising: a first elongated segment having a first end and a secondend opposite the first end, the first elongated segment defining a firstprimary lumen extending between the first and second ends, and the firstelongated segment comprising a first subsegment and a second subsegment,the first and second subsegments of the first elongated segment beingseparately insertable into a body lumen and joinable together duringsubsequent deployment in the body lumen; and a second elongated segmenthaving a first end and a second end opposite the first end, the secondelongated segment defining a second primary lumen extending between thefirst and second ends, and the second elongated segment comprising afirst subsegment and a second subsegment, the first and secondsubsegments of the second elongated segment being separately insertableinto the body lumen, wherein the first and second elongated segments areimplantable laterally adjacent with one another such that a crosssection of the first elongated segment and a cross-section of the secondelongated segment are configured to be positioned adjacent to oneanother to form a combined cross-section that is substantiallyconformable to an intraluminal cross section of the body lumen, whereinthe second subsegment of the first elongated segment and the secondsubsegment of the second elongated segment are each configured to bepositioned independently relative to each other; and wherein the firstand second elongate segments are implantable in a longitudinallydisplaced configuration from one another such that the first end of thefirst elongated segment is longitudinally offset from the first end ofthe second elongated segment.
 17. The system of claim 16, furthercomprising a first branch segment engaged to a first side opening in oneof the first and second subsegments of the first elongated segment, thefirst branch segment having a first branch lumen in fluid communicationwith the first primary lumen.
 18. The system of claim 16, furthercomprising means for joining the first and second elongated segmentstogether subsequent to deployment in the body lumen.